1. Animal Drug Import Tolerances Under ADAA of 1996 FDA’s Public Health Protection, International Harmonization, and Trade-Related Goals Merton V. Smith, Ph.D., J.D. Special Assistant for International Activities Office of the Center Director, CVM Veterinary Medicine Advisory Committee Meeting January 22, 2002

2. Increasing Emphasis on International Harmonization zGrowing volume of FDA-regulated imports zDemand for quick consumer access to new products zEuropean movement toward a unified market zBilateral and multilateral trade negotiations zNew legislative mandates zRecommendations for increased international harmonization

4. Increasing Emphasis on International Harmonization zGrowing volume of FDA-regulated imports zDemand for quick consumer access to new products zEuropean movement toward a unified market zBilateral and multilateral trade negotiations zNew legislative mandates zRecommendations for increased international harmonization

5. Policy Statements and Recommendations zFood and Drug Law Institute Study of Future Trends in Regulation (1988) zAdvisory Committee on the FDA (1991) zAdministrative Conference of the United States (1991) zWhite House Council on Competitiveness (1991) zWorld Health Organization Resolution (1992) zFDA Task Force on International Harmonization (1992) FDA Policy on International Memoranda of Understanding (1995) zFDA Policy on Standards (1995) zNational Performance Review: Reinventing Food Regulations (1996)

6. International Agreements zNorth American Free Trade Agreement (NAFTA)--signed December 17, 1992 zWorld Trade Organization Agreements (WTO)--signed April 15, 1994 zOthers: trade, environment, scientific and regulatory cooperation

7. NAFTA Provisions Covering Sanitary & Phytosanitary (SPS) Measures zEach party may establish and enforce levels of protection that it considers appropriate zMeasures must be nondiscriminatory zNo unnecessary obstacles to trade zParties shall work toward compatibility of measures and treat as equivalent measures meeting the importing party’s legitimate objectives

8. NAFTA Provisions Covering SPS Measures (continued) zInternational standards are to be used as the basis for national standards zParties can apply any measure that results in a level of protection higher than an international standard but it must be science-based and only applied to the extent necessary to achieve the established level of protection zTechnical Working Groups

9. WTO Provisions Covering SPS Measures zCountries have the right to adopt and enforce measures necessary to protect health zCountries shall ensure that measures are applied only to the extent necessary to protect health zMeasures must be nondiscriminatory zMeasures shall be based on scientific principles and not be maintained without sufficient scientific evidence

10. WTO Provisions Covering SPS Measures (continued) zImporting country must accept measures as equivalent if the exporting country objectively demonstrates to the importing country that measures achieve the importing country’s appropriate level of protection zMeasures shall be based on international standards, except where they provide a higher level of protection and then they must be scientifically justified

11. FDA Legislation Before 1997: Federal Food, Drug, and Cosmetic Act did not specifically mention international harmonization* but the following sections provide FDA’s authority: zSection 701(a) of FFDCA: broad rulemaking authority zSection 801 of FFDCA: decisions on imports zSection 301 of PHSA: broad authority for public health cooperation zSection 351 of PHSA: authority to control drugs and medical devices zSection 361 of PHSA: authority to control communicable disease

12. FDA Legislation (continued) Provisions of the FDA Modernization Act of 1997: zFDA must participate with other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve reciprocal arrangements as determined to be appropriate by FDA in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products

13. FDA Legislation (continued) Provisions of the FDA Modernization Act of 1997: zFDA must support USTR in meetings with other governments to discuss ways to reduce the burden of regulation and harmonize regulatory requirements for medical devices if FDA determines that such harmonization is consistent with the purposes of the Federal Food, Drug, and Cosmetic Act

14. FDA Legislation (continued) Provisions of the FDA Modernization Act of 1997: zSupport USTR in efforts to move toward acceptance of mutual recognition agreements relating to the regulation of drugs, biological products, devices, foods, food additives, and color additives, and the regulation of good manufacturing practices between the European Union and the United States

15. FDA Regulations and Guidance Related to International Harmonization and Equivalence Determinations z21 CFR 130.6 Review of Codex Alimentarius food standards z21 CFR Part 26 Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community zDraft Guidance on Equivalence Criteria for Food (62 FR 30593; June 4, 1997)

16. Approaches to International Harmonization by other U.S. Regulatory Agencies zAnimal and Plant Health Inspection Service zFood Safety and Inspection Service zEnvironmental Protection Agency

17. Summary FDA’s primary goal with regard to its international harmonization activities is to preserve and enhance its ability to accomplish its public health mission; including zmaintaining high standards of protection zenhancing regulatory effectiveness, and zincreasing worldwide consumer access to safe, effective, and high quality products

18. Summary (continued) zTrade agreements permit the establishment and enforcement of measures that provide a level of protection considered appropriate by the importing country. zMeasures may be more protective than international standards but they must be science-based and serve to effect the importing country’s chosen level of health protection. zWhere consistent with the consumer protection purposes of FFDCA, FDA must harmonize requirements and seek appropriate reciprocal arrangements based on determinations of equivalence

19. Summary (continued) zFDA’s regulations satisfy the obligations in NAFTA and WTO because they are nondiscriminatory, solidly grounded in science, and based on what the United States has chosen as the appropriate level of protection